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Section 8: The need for a public interest perspective

EDF supports EPA’s investment in developing new approaches to identify and characterize the potential health concerns posed by chemicals. There are practical policy-related and scientific reasons for developing new tools that:

reflect a more sophisticated and current scientific understanding of our biology;

are able to be efficiently applied at low cost to large numbers and mixtures of chemicals;

significantly improve our ability to reliably predict adverse effects chemicals may exert at various doses and stages of life and across a diverse human population;

help us understand not only whether, but also how, chemical exposures can exert adverse effects;

improve not only our ability to predict adversity but to design out of new chemicals problematic characteristics of chemicals that lead to adverse effects; and finally

are credible, understandable—at least at a basic level— and accepted by the full range of decision-makers and stakeholders.

The call for a new vision and future of toxicity testing was outlined in the National Academy of Sciences’ (NAS) 2007 publication, “Toxicity Testing in the 21st Century: A Vision and a Strategy.” The problem, as described in the report, is that “The current system, which relies primarily on a complex set of whole-animal-based toxicity-testing strategies for hazard identification and dose-response assessment, has difficulty in addressing the wide variety of challenges that toxicity testing must meet today.” The report lays out a vision for developing and incrementally integrating new methodologies into the practice of risk assessment. ToxCast is a first big step—albeit incomplete and imperfect—towards realizing that vision.

While the new testing approaches hold great promise for dealing with long-standing deficiencies in risk identification and assessment, they also present challenges that must be confronted if they are truly to lead to improvements. It is critical that these challenges, and the efforts taken to address them, are clearly communicated to the public. This is especially important as these methods begin to more formally enter into EPA decision-making activities, whether for purposes of prioritizing chemicals, informing risk assessments, or making regulatory decisions.

If federal agencies are serious about advancing these testing methods to a point where they can form the core of a new testing and assessment paradigm, there will need to be broad confidence that they can serve as a sufficient basis for making regulatory and other policy decisions. A corollary implication is that data derived using the new methods must be able to meet statutory and regulatory standards governing how the safety of a chemical is to be determined. This is the ultimate challenge: to move the new methods from the research and development phase to serve as a part of the basis for risk management and other regulatory determinations.

To meet this challenge, regulatory bodies will ultimately need to attain sufficient buy-in or acceptance from relevant stakeholders in the industry, academic, NGO and governmental sectors. And to achieve that buy-in, at a minimum each of the challenges laid out in this primer will need to be addressed. All of this will not happen overnight, of course, and will likely take many years and be constantly evolving. But it is imperative that this ultimate challenge is kept in sight, guiding the development of newer testing strategies as they move forward.

Academic scientists and public interest groups have a critical role to play in ensuring that EPA incorporates the best science into its new testing program and that these efforts serve the public interest.

Academic scientists have unique expertise and knowledge regarding experimental design, validation of data, model development, and of course, the mechanisms by which chemicals interact with, and ultimately, affect our biology. While EPA does have expertise in these areas, the ambition and promise of this endeavor demands the input of a diverse community of scientists to ensure that the best thinking and information is brought to bear in the development and use of these methods. Ultimately, these new approaches are only as strong as the science and critical-thinking upon which they are built.

Similarly, ensuring that EPA communicates and uses newer methods in a transparent and appropriate manner that meets public health needs requires the input of the public interest community. Effective engagement of this community should not be assumed to demand a high level of technical expertise, though it clearly requires some familiarity with the nature and aims of newer approaches and programs. Some of the most difficult challenges surrounding the use of these methods relate to value judgments. For example, determining acceptable levels of confidence and uncertainty for particular uses of new types of data is inherently value-laden and needs to reflect the expectations, values, and tolerances of the public. The public also has an important role to play in helping EPA to present and communicate information related to these methods in a manner that is transparent and accessible to the lay person.

A sustained dialogue between EPA and outside stakeholders including academia and the public interest community is needed. EDF created this primer as a resource for NGOs, academics and others interested in engaging to build a better future for toxicity testing and risk assessment.

To help our communities enter into and sustain a dialogue with EPA, EDF has also coordinated a series of webinars that outline the basics of the agency’s testing programs and the promises and challenges ahead. Video recordings of these sessions can be accessed through the Chemical Testing in the 21st Century: Webinar Series webpage.

Academic scientists and public interest groups have a critical role to play in ensuring that EPA incorporates the best science into its new testing program and that these efforts serve the public interest.

The expertise of academic and NGO communities is needed to help guide the development and implementation of EPA’s new chemical testing programs.